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Exer Labs, Inc. was warned for manufacturing the Exer Scan, a medical device intended for diagnosing and treating musculoskeletal and neurological disorders using artificial intelligence algorithms, without obtaining required premarket approval (PMA) or investigational device exemption (IDE) authorization. The company violated federal law by marketing the device for diagnostic and therapeutic uses that exceeded the exemptions allowed for standard exercise measurement equipment, and failed to submit a premarket notification (510(k)) before commercial distribution. The FDA's October 2024 inspection of the Denver facility identified that the device was adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act due to these missing regulatory approvals and the undisclosed change in intended use.